FDA: Consumer Warning for Weight Loss Supplement

The U.S. Food and Drug Administration (FDA) recently issued a consumer warning for the weight loss supplement MAXILOSS Weight Advanced.

The FDA found traces of sibutramine in the supplement. Sibutramine is an appetite suppressant drug that was withdrawn from the market in 2010. Thus, MAXILOSS Weight Advanced is considered an unapproved drug. This supplement has been sold online and in retail stores.

In November 2012, the FDA found sibutramine in three other weight loss supplements: Japan Hokkaido Slimming Weight Loss Pills, Beautiful Slim Body and Best Share Green Coffee: Brazilian Slimming Coffee. In December 2012, sibutramine was also discovered in Slimdia Revolution.

Sibutramine can raise blood pressure and heart rate, causing potential complications in individuals with heart disease, heart failure, arrhythmias or stroke. Sibutramine may also interact adversely with prescription drugs.

Any consumer in possession of MAXILOSS Weight Advanced should discard the product immediately. Any negative side effects should be reported to a healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information about integrative therapies for weight loss, please visit Natural Standard's Comparative Effectiveness Database.

Comments

[ML]

Just read the entry on Slimdia. I can’t believe there was another drug over the counter that also had the same ingredient. I wonder if the same manufacturer of Slimdia makes Maxiloss. Even the drugs that are approved for weight loss have adverse effects that cannot be tolerated by all. For example, people who take orlistat have complained of steatorrhea or oily, loose stools with gas. I believe that the best way to lose weight is a healthy diet and exercise.

[pc]

I agree that diet supplements seem to be a quick fix and don't help the patient focus on healthy living. The diet supplement in my local pharmacy is 12 feet long and probably 5 feet tall with shelves filled with all of the latest diet pill fads. It is a shame that people believe that diet pills will solve all of their problems with weight, as this is almost never the case. While this would be nearly impossible to implement, there should be information next to the diet pill section about healthy weight management, so people can have all the available information presented to them at one time.

[km]

Weight loss has always become the main issue for American public for the past decade. The amount of obesity has been on the rise. Sibutramine was widely prescribed by physicians as a way to suppress appetite for morbidly obese patients before they found out about cardiovascular risk. I'm glad the FDA took action to withdraw this drug from the market. Healthcare professionals should focus more on encouraging a balanced life with exercise and diet as first line treatment instead of jumping straight to medication.

[kl]

Attention consumers out there... It is important to note that the miracle weight loss drug or supplement does not exist! Any herb or supplement label that sounds too good to be true most likely is too good to be true! If you are interested in taking a weight loss product you should consult with a qualified healthcare provider. Together, you both can devise a weight-loss plan that is both safe and effective. Don't assume that because you buy it on the shelf in the pharmacy it is safe!

[af]

In my opinion, warnings like this bring an unfortunate human trait to mind: ignorance. When I was an undergraduate student, I was friends with many of the players on the football team. Their dorm rooms were all stocked with large containers of protein and weight loss supplements, and now that I have learned a great deal about herbs and supplements, I can’t help but wonder if those athletes even knew what was in them and what they were putting into their bodies each day. Did any of them have a family history of hypertension or heart disease? If so, did they know that some of the substances in these supplements could put their health at risk? There seems to be a general lack of knowledge about what exactly is in these weight loss products, which is, in my opinion, scary to think about.

[af]

When I read about weight loss supplements like this, I am always reminded of how they serve as quick fixes for too many people when it comes to losing weight. I have witnessed people close to me take advantage of supplements or extreme diets (such as those that entail cutting out all carbohydrates) to lose weight. Once the weight starts coming off, many people lack the self discipline to even attempt introducing a healthy diet and physical activity into their routines for weight loss. In this way, supplements can play a “bad guy” role, which is why healthcare providers must stress the importance of the health component of weight loss (diet and exercise) to those who express a desire to lose weight as often as possible.

[NL]

I agree. This is very scary. I am thinking this is probably not the only OTC weight loss supplement that raises such concerns. Weight loss supplements like this can be very harmful and cause severe cardiovascular effects. Still, the use of these supplements is becoming more and more common because patients are looking for a quick fix.

[a]

Just looking at the names of these supplements, especially "Beautiful Slim Body," makes me skeptical. When it comes to products for weight loss, in particular, patients need to be very careful that they understand the safety and efficacy behind their claims. Some these products have a history of unsafe cardiovascular effects or poor efficacy and it surprising that many of them can still be on the market.

[AM]

Just to play devil's advocate here: While it is true that having the FDA analyze and approve all OTC products would reduce the number of these products on the market, the dietary supplement industry specifically lobbied for the creation of the separate "dietary supplement" designation to avoid being regulated and classified as a drug. If OTC drugs and dietary supplements had to be approved, it would cost a lot more money that it does at the moment, and require so much more time to market. This would mean that many honest OTC manufacturers would be hurt by the addition of regulation. As it is, in many cases, it takes years for the FDA to approve Rx-Only drugs! Reformulations of OTC drugs happen all the time. Look at the APAP dose reductions that are occurring. This would cripple the FDA if they had to approve each one of the new reformulations. The method used for approved OTC drugs is one that was built out of budgetary necessity, rather than want. I'm sure they would much rather check everything on the market, but it's just not feasible given the current restraints.

[bz]

Mislabeling of supplements is becoming quite a major problem lately. This blog alone reported at least 3 mislabeled products in the last month! Clearly more government oversight is needed to prevent prescription medications from showing up in over the counter supplements, but the financial commitment to such an endeavor is likely preventing this from happening. How many more problems need to arise before something can be done? Companies making supplements out of our country cannot be the only ones held accountable for their product composition.

[js]

It’s scary that some OTC products may contain ingredients that aren’t on the label and this seems like it has happened multiple times. Why doesn’t the FDA analyze products before they are put on the market instead of pulling them after the fact? They don’t even have to test for efficacy but maybe just safety and that the product contains the ingredients that it states on the label. I believe this way of monitoring dietary supplements would be safer for the consumer.